Senior Quality Assurance Lead, Manufacturing Excellence

Par Health; Rochester (MI); On-site; USD 110,000 - 160,000; Full time

Job summary

Par Health in Rochester, MI is seeking a Senior Quality Specialist to review batch records and COAs, ensure timely product release, and lead quality investigations. You will drive CAPAs, change controls, and continuous improvement with cross-functional teams to meet cGMP and FDA standards.

The role requires a bachelor’s in a scientific/technical field and at least 7 years in regulated manufacturing environments, with strong analytical and writing skills.

Qualifications

• Bachelor's degree in a scientific, technical, engineering, quality or related discipline.
• Minimum of 7 years of experience in pharmaceutical, biotechnology, medical device, or other regulated environments.
• Experience in Quality Assurance, Manufacturing QA, Quality Control, Inspection or Quality Systems.
• Working knowledge of cGMP, GDP, FDA regulations and pharmaceutical quality systems.
• Experience with defect characterization, investigations, CAPA, and quality risk assessments.

Responsibilities

• Review batch records, production docs, logbooks and quality records for accuracy and compliance.
• Release products and manage holds, quarantines, and related quality events.
• Lead investigations, CAPAs, deviations, change controls and continuous improvement efforts.
• Provide training and guidance on defect recognition and quality assessment practices.
• Collaborate with cross-functional teams to ensure product quality decisions and regulatory readiness.

Skills

Critical Thinking

Analytical Problem Solving

Quality Risk Assessment

Investigation & Root Cause Analysis

Technical Writing

Education

Bachelor's degree in a scientific, technical, engineering, quality, or related discipline

Tools

ERP systems

Microsoft Office

Job description

Par Health in Rochester, MI is seeking a Senior Quality Specialist to review batch records and COAs, ensure timely product release, and lead quality investigations. You will drive CAPAs, change controls, and continuous improvement with cross-functional teams to meet cGMP and FDA standards.

The role requires a bachelor’s in a scientific/technical field and at least 7 years in regulated manufacturing environments, with strong analytical and writing skills.